If you or your child needs ear tubes, you may be interested in a clinical study being conducted at Advanced ENT & Allergy in Louisville.
Advanced ENT & Allergy is participating in a clinical study evaluating the CLiKX® Tympanostomy Tube Delivery System, an investigational device designed to assist physicians with the placement of tympanostomy tubes, also known as ear tubes.
The study is being conducted with Dr. Steven Shotts, M.D., as the Primary Investigator.
Ear tubes, also called tympanostomy tubes or ventilation tubes, are small tubes placed through the eardrum to help manage certain ear conditions.
They may be recommended for patients who experience problems such as:
During a typical ear tube procedure, a small opening is made in the eardrum, and the tube is placed through the opening.
The CLiKX clinical study is evaluating the safety and performance of the CLiKX Tympanostomy Tube Delivery System in patients who require tympanostomy tube placement.
The investigational device is designed to assist with the myringotomy procedure and delivery of the ear tube into the intended position.
The study will evaluate whether the device can successfully assist with ear tube placement while also monitoring patient safety and how well patients tolerate the procedure.
This is a prospective, single-arm clinical study. The study is expected to enroll approximately 80 participants, including both children and adults who are scheduled to undergo tympanostomy tube insertion.
Patients who qualify for the study will undergo the planned tympanostomy tube procedure using the CLiKX device.
The research team will evaluate factors such as:
Participants will have follow-up after the procedure, including a 30-day follow-up visit, so the research team can continue monitoring safety and outcomes.
The study may be an option for children and adults who are already scheduled to have tympanostomy tubes placed.
Some of the study's eligibility requirements include:
Additional eligibility requirements apply, and not everyone who needs ear tubes will qualify. The study team will determine eligibility based on the full study criteria.
The CLiKX study is classified as a non-significant risk (NSR) study. This is a regulatory classification related to the level of risk associated with the investigational device and study procedures.
Being part of an NSR study does not mean that there are no risks. As with any medical procedure or clinical study, there may be potential risks and side effects. The research team will explain the study, including its potential risks and benefits, before you decide whether to participate.
If you or your child is scheduled to receive ear tubes and you would like to learn more about the CLiKX clinical study, the research team at Advanced ENT & Allergy can help determine whether you may qualify.
Primary Investigator:
Steven Shotts, M.D.
Advanced ENT & Allergy
Rhonda Dase, Study Coordinator
(502) 399-1885 x 80071
rdase@advancedentandallergy.com
Study:
CLiKX® Tympanostomy Tube Delivery System Clinical Study
If you are interested in participating, contact the Advanced ENT & Allergy clinical research team to learn more about eligibility and what participation involves.
Participation in a clinical study is voluntary. The study team will review the details of the study with you and answer your questions before you decide whether to participate.